Unable to Generate PMDA E2B when Study J License field is blank
(Doc ID 2237219.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety Japan Cloud Service - Version 8.0 and laterInformation in this document applies to any platform.
Symptoms
E2B report for PMDA agency is unable to be generated on a study case when Argus Console >> Business Configuration >> Studies >> J Data Entry >> Products block >> License field is missing/blank.
(When LM_STUDY_PRODUCTS.PRIMARY_PMDA_PRODUCT_LIC_ID is NULL.)
PMDA ICSR Validation Report message:
Missing Mandatory Elements:
J.12.i.1 MHLWINDICATIONFORSTUDY Target Disease
J.12.i.2 MHLWPHASEOFSTUDIES Study Development Phase
J.12.i.3 MHLWNUMBOFPTUNDERTREATMENT Are any subjects given this investigational drug?
J.12.i.1 MHLWINDICATIONFORSTUDY Target Disease
J.12.i.2 MHLWPHASEOFSTUDIES Study Development Phase
J.12.i.3 MHLWNUMBOFPTUNDERTREATMENT Are any subjects given this investigational drug?
Changes
Cause
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In this Document
| Symptoms |
| Changes |
| Cause |
| Solution |
| References |